MAUDE Adverse Event Report: DATASCOPE CORP. CUSTOM TUBING PACK; CARDIOPULMONARY

Model Number BO-TOP-30300

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2015

Event Type  malfunction  

Event Description

The perfusionist claims that when he was trying to prime the circuit that the overpressure line would not allow fluid to flow through it.There is a one way valve in the line.He thinks maybe some bonding occluded the line.

Manufacturer Narrative

Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Internal complaint number - (b)(4).

• Brand Name: CUSTOM TUBING PACK
• Type of Device: CARDIOPULMONARY
• Manufacturer (Section D): DATASCOPE CORP.; fairfield NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR, LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4751319
• MDR Text Key: 5888904
• Report Number: 2248146-2015-00032
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Model Number: BO-TOP-30300
• Device Lot Number: 17613-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1